Ibudilast for Treating Alcohol Use Disorder

NCT05414240 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 851593
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study involving 6 weeks of study medication, Ibudilast or a placebo (an inactive substance) and medical management counseling to reduce or stop drinking. Ibudilast is not approved by the U.S. FDA for clinical use in the United States, but it is has been used for many years in Japan for its anti-inflammatory effects. Its use in the treatment of alcohol dependence is experimental. By reducing inflammation, Ibudilast may help some people reduce or stop drinking. We have obtained an Investigational New Drug Application (IND) approval for this study from the FDA. Ibudilast has been used clinically for 20 years in Asia for treating bronchial asthma and, more recently, for post-stroke dizziness and ocular allergies and has been shown to be safe and well tolerated.

Conditions

Alcohol Use Disorder (AUD); Alcoholism

Keywords

Ibudilast; alcohol

Outcome Measures

Primary Outcomes (1)

• Change in the frequency of heavy drinking

  Frequency of heavy drinking (defined as 4 or more drinks in a day for women and five or more drinks in a day for men).

  6-week treatment period.

Secondary Outcomes (1)

• Change in the number of abstinent days, heavy drinking days during the last month of treatment.

  6-week treatment period.

Study Arms (2)

Ibudilast

ACTIVE COMPARATOR

IBUD at a dosage of 20 mg twice daily for 2 days, with an increase to 50 mg twice daily on day 3. The dosage will remain at 50 mg twice daily through most of the rest of the 6-week treatment period. However, for the last three days of week 6, participants will reduce the dosage gradually to 20 mg twice daily prior to discontinuing it at the end of the treatment period.

Drug: Ibudilast; Behavioral: Medical management

Inactive placebo

PLACEBO COMPARATOR

Placebo twice daily for 6-week treatment period. Placebo will match active medication in appearance and size.

Behavioral: Medical management; Drug: Placebo

Interventions

Ibudilast DRUG

IBUD at a dosage of 20 mg twice daily for 2 days, with an increase to 50 mg twice daily on day 3. The dosage will remain at 50 mg twice daily through most of the rest of the 6-week treatment period. However, for the last three days of week 6, participants will reduce the dosage gradually to 20 mg twice daily prior to discontinuing it at the end of the treatment period.

Also known as: MN-166, previously known as AV411 and the formulation is 10-mg delayed-release Pinatos® capsules

Ibudilast

Medical management BEHAVIORAL

All subjects receive 6 weeks of medical management (Pettinati et al. 2004) will support subjects efforts to reduce or stop their drinking.

Ibudilast; Inactive placebo

Placebo DRUG

Placebo twice daily for 6-week treatment period. Placebo will match active medication in appearance and size.

Also known as: Inactive substance

Inactive placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physically healthy, based on medical history and physical examination and approval of the study physician
• Meets current DSM-5 criteria for AUD
• Average weekly ethanol consumption of \>24 standard drinks for men and \>18 standard drinks for women, with a weekly average of \> 2 HDDs during the month before screening
• Stated goal to reduce drinking to safe levels or to stop drinking
• Able to read English at an 6th grade or higher level and no gross cognitive impairment
• Willingness to nominate an individual who will know the subject's whereabouts to facilitate follow up during the study
• Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or less than two years postmenopausal) must be non-lactating and practicing a reliable method of birth control and have a negative urine pregnancy test prior to the initiation of treatment. Examples of medically acceptable methods for this protocol include: the birth control pill, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence), and tubal ligation.
• Willingness to provide signed, informed consent and commit to completing the procedures in the study

You may not qualify if:

• A current, clinically significant physical disease or abnormality based on medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of \>110% or a transaminase elevation \>300% of normal
• Current, serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, panic disorder, borderline or antisocial personality disorder, organic mood or mental disorders, eating disorder, or imminent suicide or violence risk)
• Current DSM-5 diagnosis of dependence on a drug other than alcohol, marijuana or nicotine
• Current regular treatment with a psychotropic medication (e.g., benzodiazepines, anticonvulsants), which affect neurotransmitter systems, or a medication to treat alcohol dependence. Stable antidepressant treatment for at least 1 month is acceptable.
• Judged by the principal investigator or his designee to be an unsuitable candidate for receipt of an investigational drug

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

ibudilast; Practice Management, Medical

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Henry R Kranzler, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiarty

Model Details: Randomized, double-blind, placebo-controlled, parallel-groups design

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: January 14, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

US (1)